FDA.reportPublic FDA data

MERIFLUOR Pneumocystis

Primary DI
00840733101106
Brand
MERIFLUOR Pneumocystis
Company
MERIDIAN BIOSCIENCE, INC.
Model
222030
Catalog number
222030
Device description
MERIFLUOR Pneumocystis is an in vitro direct immunofluorescent detection of Pneumocystis carinii cysts and trophozoites in direct smears of respiratory tract specimens.
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LYFPneumocystis Carinii

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYFPneumocystis CariniiMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840733101106PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840733101106008407331011068407331011060840733101106

GMDN Terms#

Term, Definition table
TermDefinition
Pneumocystis jirovecii antigen IVD, kit, direct fluorescent test (DFT)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from the fungus Pneumocystis jirovecii (formerly known as P. carinii) in a clinical specimen, using a direct fluorescent test (DFT).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
513-271-3700info@meridianbioscience.com

Regulatory Flags#

DUNS number
092815364
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840733101595StatID PRO COVID/Flu A&B Swabs7831107831102026-05-14
00840733101557statID Pro COVID-19/Flu External Controls7830102026-04-10
00840733101564statID Pro COVID-19/Flu A&B7830252026-04-10
00840733101717PREMIER CAMPY6180966180962020-09-01
00840733101397Fungal Immunodiffusion Plates - 4 Series1010091010092019-11-21
00840733101403Fungal Immunodiffusion Plates - 1 Series1010121010122019-11-21
00840733101014ANA Screen ELISA Test Kit488426148842612016-09-23
00840733102585Hemo-De8013008013002020-12-09
00840733102660Modified Hemo-De8016008016002020-09-21
00840733102318Revogene6102106102102020-07-15
00840733102547EcoStain8014008014002020-12-09
00840733102394SpinCon9722009722002020-10-26
00840733103285Revogene Check6102206102202022-06-27
00840733103339Para-Pak C&S9006-019006122021-06-18
00840733102011Para-Pak C&S9006129006122020-12-09
00840733102714Para-Pak C&S9006129006122020-12-09
00840733102455Para-Pak Ultra SAF9802129802122020-12-09
00840733102851Para-Pak Ultra SAF9802129802122020-12-09
00840733101304MERIFLUOR GullSORB XX715XX7152016-09-23
00840733102899Para-Pak SAF in Tubs9901609901602020-12-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04053252730351Light Diagnostics PCP DFA ReagentEMD Millipore CorporationLYF2020-04-17
04053252401121Light Diagnostics™ Pneumocystis Carinii DFA EMD Millipore CorporationLYF2016-09-26
00847865001502MONOFLUOBio-RAD Laboratories, Inc.LYF2016-09-12
00847865001519MONOFLUOBio-RAD Laboratories, Inc.LYF2016-09-12